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The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery

Primary Purpose

Gender Dysphoria, Opioid Use, Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine 0.2% Injectable Solution
Saline (0.9%)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gender Dysphoria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class I-III
  • Ages 18-65
  • Undergoing gender confirmation breast reduction surgery by a single surgeon at a single center

Exclusion Criteria:

  • Previous breast surgeries
  • Current breast cancer or history of treatment for breast cancer
  • Current chronic pain syndromes
  • Coagulopathy
  • Allergy to local anesthetics
  • Infection at the injection site

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Saline

Ropivacaine

Arm Description

Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.

Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).

Outcomes

Primary Outcome Measures

Comparison of Post Operative Pain Scores
Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.

Secondary Outcome Measures

Comparison of Intra Operative Narcotic Requirements
Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.
Comparison of Post Operative Narcotic Requirements
Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.

Full Information

First Posted
June 29, 2020
Last Updated
June 27, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04474366
Brief Title
The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery
Official Title
The Effect of Pectoral Blocks on Perioperative Pain in Simple Mastectomy and Breast Reduction in Gender Affirmation Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite recent advancements with regional and local anesthesia, postoperative pain continues to be a major concern for patients undergoing breast surgery. Opioids, often in combination with NSAIDS and/or gabapentioids, have been the main pharmacologic pain control strategy in the postoperative period. The pectoral nerve block is a regional anesthetic technique, which is effective at providing postoperative anesthesia in breast surgeries. However, this has only been studied in oncologic-related breast operations. It is our aim to study the effects of pectoral regional nerve blocks in patients undergoing breast reduction for gender affirmation. The overall goal is to establish an effective pain control regimen utilizing regional anesthetic techniques in this patient population. The specific objective of this proposal is to evaluate the effectiveness of these blocks on perioperative and postoperative analgesia. The hypothesis is that participants undergoing gender-affirmation breast surgery who receive a pectoral nerve block will have less perioperative and postoperative pain as well as reduced opioid consumption compared to those receiving a placebo. Participants who are undergoing gender affirmation breast reduction surgery will be randomized to either receive a preoperative nerve block or to receive a placebo. Intraoperative and postoperative opioid requirements will be compared in addition to post-operative pain scores. Participants will be asked to fill out a pain diary during their first week postoperatively. They will also be asked to document if, and when, narcotic pain medication was required for pain control. The two groups will be compared to determine if there was any difference in pain scores as well as narcotic medication requirements.
Detailed Description
All participants will be seen in clinic with the attending surgeon anywhere from two weeks to a few months prior to the date of surgery. Participants will also have a pre-op visit with anesthesia a few weeks before surgery. They will undergo a standard anesthesia preoperative evaluation, which will include a medical chart review, physical exam, and appropriate laboratory studies. The preoperative evaluation will be identical for those participating in the study and those who do not. If no contraindications to the Pectoralis Nerve Block (PECS I and II block) are identified by the surgeon and/or anesthesiologist, participants will be approved to participate. The participants will be introduced to the study either during their clinic visit prior to surgery or over the telephone a few days prior to surgery. All questions will be answered by one of the study investigators. A study consent will be obtained from the participants and they will then will be randomized into either control (sham block) or experimental (PECS I and II block) group. On the day of surgery, as per standard of care, each participant will undergo a general anesthetic in the same manner with conventional perioperative management. During induction of anesthesia, up to 2mg of midazolam and/or up to 100mcg of fentanyl will be given. The above protocol will be followed regardless of study participation and study group (if participating). After induction of anesthesia, the nerve blocks, or control blocks, will be performed. The regional anesthesia team will be involved in all patients, whether in the control or intervention group. All patients will be come and go regardless of group. Group 1 (control) will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally. Group 2 (treatment) will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally. (Not to exceed 225mg or 3.5mg/kg). PECS I and II Block Technique: Performed in the supine position with the arms abducted 90 degrees at the shoulder. Using an ultrasound transducer in the parasagittal plane, the axillary artery and vein are identified just inferior to clavicle and medial to coracoid process. Additionally, the 2nd rib is identified and the transducer is slid inferiorly until the 3rd and 4th rib are identified. At this point the pectoralis major, minor, and serratus anterior muscles are seen. Then the block needle is inserted through the skin and advanced into the fascial plane between pectoralis minor and serratus anterior muscles. After negative aspiration, the anesthetic is injected into the plane watching for hydrodissection of the muscles. A total volume of 20ml is injected. Then the needed is withdrawn until the tip is located in the fascial plane between the pectoralis major and minor muscles. 10ml of anesthetic is injected into this plane. General anesthesia is maintained in the standard fashion. The anesthesiologist will administer Fentanyl as he or she feels necessary during the operation. Post operatively, in the PACU, participants will be given IV hydromorphone as needed for pain. Pain scales will be documented at set time points post operatively and participants will be given pain diaries to document these pain scores as well as their opioid consumption. All patients will be sent home with a prescription for 20 tablets of Norco 5mg/325mg. Participants will be asked to document their pain scores at the following post op time points: 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 1 week. Participants will return their pain diaries at the 1 week post operative visit. This visit is a standard of care follow up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria, Opioid Use, Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Sham Comparator
Arm Description
Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.
Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% Injectable Solution
Intervention Description
Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
Intervention Type
Other
Intervention Name(s)
Saline (0.9%)
Intervention Description
Saline injection as sham block in identical fashion as Pectoralis Nerve Block
Primary Outcome Measure Information:
Title
Comparison of Post Operative Pain Scores
Description
Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.
Time Frame
1 week post operative
Secondary Outcome Measure Information:
Title
Comparison of Intra Operative Narcotic Requirements
Description
Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.
Time Frame
Intraoperative
Title
Comparison of Post Operative Narcotic Requirements
Description
Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.
Time Frame
1 week post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) class I-III Ages 18-65 Undergoing gender confirmation breast reduction surgery by a single surgeon at a single center Exclusion Criteria: Previous breast surgeries Current breast cancer or history of treatment for breast cancer Current chronic pain syndromes Coagulopathy Allergy to local anesthetics Infection at the injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Kim, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Anyone who wishes to access the data. For any purpose.
Citations:
PubMed Identifier
25376971
Citation
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Results Reference
background
PubMed Identifier
29241077
Citation
M N, Pandey RK, Sharma A, Darlong V, Punj J, Sinha R, Singh PM, Hamshi N, Garg R, Chandralekha C, Srivastava A. Pectoral nerve blocks to improve analgesia after breast cancer surgery: A prospective, randomized and controlled trial. J Clin Anesth. 2018 Mar;45:12-17. doi: 10.1016/j.jclinane.2017.11.027. Epub 2017 Dec 11.
Results Reference
background
PubMed Identifier
23510637
Citation
Benotsch EG, Zimmerman R, Cathers L, McNulty S, Pierce J, Heck T, Perrin PB, Snipes D. Non-medical use of prescription drugs, polysubstance use, and mental health in transgender adults. Drug Alcohol Depend. 2013 Sep 1;132(1-2):391-4. doi: 10.1016/j.drugalcdep.2013.02.027. Epub 2013 Mar 17.
Results Reference
background
PubMed Identifier
28942238
Citation
Day JK, Fish JN, Perez-Brumer A, Hatzenbuehler ML, Russell ST. Transgender Youth Substance Use Disparities: Results From a Population-Based Sample. J Adolesc Health. 2017 Dec;61(6):729-735. doi: 10.1016/j.jadohealth.2017.06.024. Epub 2017 Sep 21.
Results Reference
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The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery

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